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PROFESSIONAL MEDICAL PRODUCTS
SFIGMOMANOMETRO
ARM BLOOD PRESSURE MONITOR
TENSIOMÈTRE À BRASSARD
MONITOR DE PRESIÓN ARTERIAL DE BRAZO
MONITOR DA TENSÃO ARTERIAL DE BRAÇO
OBERARM-BLUTDRUCKMESSGERÄT
ARMBLOEDDRUKMETER
ARMMONITOR FÖR BLODTRYCK
CIŚNIENIOMIERZ NARAMIENNY
KAR VÉRNYOMÁSMÉRŐ MONITOR
TENSIOMETRU ELECTRONIC DE BRAȚ
ΠΙΕΣΌΜΕΤΡΌ ΜΠΡΆΤΣΌΥ
Manuale d'uso
User Manual
Mode d'emploi
Manual de Usuario
Manual do Utilizador
Bedienungsanleitung
Gebruikershandleiding
Användarmanual
Instrukcja obsługi
Felhasználói kézikönyv
Manual de utilizare
Εγχειρίδιο Χρήσης
GIMA 49870
Shenzhen AOJ Medical Technology Co., Ltd.
Room 301&4F, Block A, Building A,
Jingfa Intelligent Manufacturing Park,
Xiaweiyuan, Gushu Community, Xixiang Street,
Bao'an District, 518126 Shenzhen, PEOPLE'S
REPUBLIC OF CHINA
Made in China
AOJ-33A
0123
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Related Manuals for Gima AOJ-33A
Summary of Contents for Gima AOJ-33A
- Page 1 Gebruikershandleiding Användarmanual Instrukcja obsługi Felhasználói kézikönyv Manual de utilizare Εγχειρίδιο Χρήσης GIMA 49870 Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao’an District, 518126 Shenzhen, PEOPLE’S REPUBLIC OF CHINA...
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Page 2: Table Of Contents
ENGLISH Table of Contents 1. Unpacking Inspection 2. Packing List 3. Symbol Definition 4. Product Composition 5. Intended Use / Instructions for Use 6. Contraindication 7. Product Parts 8. 3-color Backlit Indicator 9. Preparation:Type-C Charging 10. Function Setting 11. How to Take Proper Measurements 12. Warnings and Cautions 13. Common Q & A on Blood Pressure Q2:Why is the blood pressure value obtained at home higher than that obtained at the hospital? Q3:When can I obtain better measurements? Q4.Why the blood pressure value measured each time is different? 14. Abnormal Phenomena and Handling 15. Cleaning and Disinfection 15.1 Cleaning 15.2 Disinfection 15.3 Disposal 16. Upkeep and Maintenance 17. Specifications 18. Appendix 1 EMC Information... -
Page 3: Unpacking Inspection
ENGLISH Thank you for purchasing the Arm Blood Pressure Monitor. The device uses the oscillometric method of blood pressure measurement. It is intended for professional and domestic use in monitoring diastolic and systolic blood pressure and pulse rate. The device can be used in homecare environment, and the patient is an intended operator, and all the functions can be safely used. This monitor complies with the requirements of ISO 81060-2. 1. Unpacking Inspection Before use, please open the package carefully and check whether all the parts are available according to the following packing list and whether the parts are damaged during transportation, and then install and operate in strict accordance with the manual. 2. Packing List Name Quantity Arm Blood Pressure Monitor with Cuff User Manual Quick Start Guide Bluetooth Quick Start Guide Type-C Charging Cable... -
Page 4: Symbol Definition
ENGLISH 3. Symbol Definition The warnings and illustrations shown in the manual are intended to enable you to use the device safely and correctly, thus preventing harm to you and others, specific meanings of which are shown as follows: Caution: read instructions (warnings) carefully Type BF applied part WEEE disposal Follow instructions for use Keep in a cool, dry place Low voltage prompt Keep away from sunlight High 2 Protected against the entry of solid foreign bodies of dimensions equal to or greater than 12.5 mm; 2 Protected against the ingress of water drops when the device is tilted up to 15° RoHS RoHS mark CE mark... -
Page 5: Product Composition
ENGLISH 4. Product Composition This device is composed of the main body and cuff. 5. Intended Use / Instructions for Use The Arm Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home. Intended users 1.Lay person or clinical professionals. 2.can read and understand the user manual. Clinical benefit Patients can monitor systolic pressure, diastolic pressure and pulse rate at home at any time, greatly reducing the number of visits to the hospital, reducing the risk of travel and improving the quality of patient’s life. -
Page 6: Product Parts
ENGLISH 7. Product Parts (1)Main Body (2)Display Outline... -
Page 7: Color Backlit Indicator
ENGLISH 8. 3-color Backlit Indicator Hierarchi- Systolic Blood Diastolic Blood Color of cal Rela- Pressure(mmHg) Pressure(mmHg) Indicator tionship ≥160 ≥100 and (or) 140-159 90-99 Yellow and (or) 90-139 60- 89 Green and (or) <90 <60 Yellow and (or) Warning: When the blood pressure indicator is red, it means you are hypertension. - Page 8 ENGLISH (2) Year/Month/Date Setting In power-off mode, press the “ “ button for about 3 seconds to enter the date setting, and “year” will flash. Press the “ “ button to adjust to the desired year, and then press the “ “ button to confirm the selection. When the”year” is set, it will automatically enter the month setting. At this time, the “month” icon will flash. You can switch to the desired value by pressing the “ “ button. Follow the same step to set “date”, “hour”, and “minute”. (3) Unit Display Setting In power-off mode, keep pressing the “ “ button for about 3 seconds to enter the unit selection. Press the “ “ button to switch between mmHg and kPa, and then press the “ “ button to confirm the selection. The default unit is mmHg.
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Page 9: How To Take Proper Measurements
ENGLISH 11. How to Take Proper Measurements (1) Preparation before measurement Always measure in the same arm (generally the left arm). --Remain still and keep quiet during measurement. --Relax as much as possible and do not talk during measurement PROCEDURE. --Measure your blood pressure at about the same time every day. --Do not measure right after physical exercise or a bath. Rest for 20 to 30 minutes before taking the measurement. --Readings under the conditions listed below may affect results: Within an hour after dinner, after having wine, coffee, tea, sports; talking, being nervous, being in unsteady mood, bending forward, moving, room temperature dramatically changing during measuring; inside a moving vehicle, repeated and continuous measuring. (2) Wearing the cuff correctly 1) Unroll the cuff. Place your arm inside it. (We strongly recommend to use your left arm.) 2) Make sure that the device’s screen is positioned on your inner arm as illustrated in the diagram. The bottom edge of the cuff should be 0.8-1.2 inches (2 to 3 cm) above the inside elbow. - Page 10 ENGLISH 3) Tighten the cuff around your arm, so it can not move around your arm. Note: Repeated measurement may result in blood congestion in the arm, which will affect the measurement result. Be careful not to rest your arm on the air tube.To avoid this situation, we advise that you can raise the left hand and hold the fist for several times, or take off the cuff and rest for at least 2-3 minutes before taking the measurement. (3) Measurement tips • To take a measurement, you need to be relaxed and comfortably seated in a room with a comfortable temperature. • Sit in a comfortable chair with your back and arm supported. • Keep your feet flat and your legs uncrossed. • The device should be placed on your inner arm at the same level as your heart, with the arm resting comfortably on a table. (4) Taking a measurement Press the “ “ button and the monitor will begin to inflate. Please do not move or talk during the measurement.
- Page 11 ENGLISH Note: If you feel uncomfortable during the measurement, press the “ “ button immediately to stop measure. When the air pressure is filled to a certain value, the value on the display screen will slowly drop at a certain speed, and the heartbeat symbol will flash. After the measurement is completed, the systolic pressure, diastolic pressure, and pulse measurements will be displayed on the screen. Note: Consult your doctor if unexpected readings are obtained. (5) Memory function 1) Each measured value is stored automatically under the appropriate “User” group. This device can store up to 120 sets of measurements for each user. (Note: There is no memory for “Guest”.) Once the memory log is full, old values are refreshed with new ones.
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Page 12: Warnings And Cautions
ENGLISH (8) “Keep Still” indication The “ “ icon flashes when you move the body or shake the hand during the measurement, which may cause incorrect measurement results. Please measure again. (9)Turn off the unit Press “ “ button to turn off the arm blood pressure monitor. The monitor automatically turns off after 1 minutes. 12. Warnings and Cautions Warnings ● No maintenance or servicing when using. ●Too frequent measurements can cause injury to the PATIENT due to blood flow interference. ●Consult with your physician before using this monitor on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow which could result in injury. ●Consult with your physician before using this monitor if you have had a mastectomy or lymph node clearance. ●Do not use the monitoring ME EQUIPMENT on the same limb simultaneously. This could temporarily cause loss of function or an inaccurate measurement. ●Please check whether the operation of the Arm blood pressure monitor leads to prolonged impairment of patient’s blood circulation by observing the limb concerned. - Page 13 ENGLISH ● DO NOT use this monitor for infants, toddlers, children or persons who cannot express themselves. ● DO NOT take medicine based on readings from the device. Contact your physician for specific information about your blood pressure. The patient should not self-diagnose or self-medicate per measured results. Kindly adhere to the instructions of your physician or health provider. DO NOT use the device while you are on an intravenous drip or blood transfusion. ● DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in incorrect operation of the monitor and/or cause an inaccurate reading. ●Make sure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or intravascular therapy,or an arteriovenous(AV)shunt. ● Consult with your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, pregnancy, pre-eclampsia or renal disease. NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading. ● Stop using this monitor and consult with your physician if you experience skin irritation or discomfort. ● Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders, because the cuff inflation can cause bruising. ● DO NOT use this monitor for any purpose other than measuring blood pressure and pulse rate. ● DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading. ● DO NOT use in a location where there is moisture or a risk of water splashing this monitor.
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Page 14: Common Q & A On Blood Pressure
ENGLISH several minute. ●Do not operate when charging. 13. Common Q & A on Blood Pressure Q1: Why is the blood pressure value obtained at home lower than that obtained at the hospital? ● The blood pressure difference between home and hospital measurements is about 20 mmHg - 30 mmHg (2.7 kPa - 4.0 kPa). This is because individuals tend to be more relaxed at home than at the hospital. ● Also, when the device is placed at a position over the heart, the blood pressure value tends to be much lower than it actually is. Ensure the device is positioned right at the heart level. Q2: Why is the blood pressure value obtained at home higher than that obtained at the hospital? ● The anti-hypertensive drug the patient might be using has lost its efficacy. Kindly adhere to your doctor’s instructions. -
Page 15: Abnormal Phenomena And Handling
ENGLISH 5mmHg-10mmHg (0.7kPa-1.3kPa) lower than the first time. This will be more obvious for those with higher blood pressure. --When continuous measurement, please note that: There might be extravasated blood because the arm is compressed, resulting that the finger tip blood does not flow smoothly, If you continue the measurement in case of extravasated blood, you cannot obtain the correct measured value. Loosen the arm band, raise your hand over the head, and grasp and stretch your left and right palms for 15 times repeatedly. Then the extravasated blood can be dissolved, and you can continue the blood pressure measurement. 2) Cuff position and twining method. The measured value varies with the cuff size. Particularly, if the cuff is twined round the elbow, you cannot obtain the correct measured value. --Please use the correct cuff twining method for measurement. The arm circumference range of the enclosed cuff is 22~42cm (center of the upper arm). If the model is inconsistent, please purchase separately. 14. Abnormal Phenomena and Handling If the measurement is abnormal, any of the following symbols may appear. Kindly use the recommended method for measurement. Errors Cause The inflation can not reach 30 mmHg Er U in 12 seconds. Er H The inflation reaches 295mmHg, Er 1 The pulse rate is not detected correctly. Too much disturbance (Move, talk, or magnetic Er 2 disturbance during a measurement). -
Page 16: Cleaning And Disinfection
ENGLISH *Troubleshooting Anomaly Inspection Items Countermeasures Recharge the The battery is device till the “ “ Failure to power on depleted indicator stops flashing Whether the arm Keep your arm and is moved when body still Unable to measure pressurization due to display error Whether you talk Keep quiet while during measure- measuring the ment blood pressure Please contact the dealer to replace The airbag of the Air leakage of cuff with a new cuff. -
Page 17: Disposal
16. Upkeep and Maintenance - Always keep the surface of monitor clean and tidy, helpful to prolong the service life of Blood Pressure Monitor. - If the host is dirty, please wipe with a dry soft cloth. If the dirt cannot be eliminated easily, wipe with a soft cloth stained with water or neutral detergent, and then dry with a dry cloth. -We suggest to calibrate the monitor once a year at least. Please contact manufacturer or agent if you need. Warning: Do not allow water or other liquids to flow into the device.The arm pressure monitor should not no longer be reused when liquid enter and damage the device and cuff. 17. Specifications Model AOJ-33A Display LED Screen Measuring Oscillometric measurement Method... - Page 18 ENGLISH Measuring Upper arm Part Pneumatic Pressure 0~295 mmHg (0~39,3 kPa) Measuring Range Maximum Pressure 295 mmHg (39,3 kPa) Protection Blood SIS: 57~255 mmHg (7,6~34,0 kPa); Pressure DIA: 25~195 mmHg (3,3~26,0 kPa); Measurement Value Range Pulse Rate 40~199 bpm Accuracy of the cuff ±3 mmHg(±0,4kPa) pressure Accuracy of ±5% the pulse rate It can be used for 3 users (user 1, user 2 and guest mode). Memory 2 users*120 memories and guest mode without memory.
- Page 19 ENGLISH Protection Against Har- mful Ingress IP22 of Water or Particular Matter Service Life 5 years Protection Against Internally powered supply Electric Shock Cuff Service 10000 times life If stored Temperature 5 °C~40 °C or used Condition beyond the 15%~90% designated Operating Humidity umidità temperature Environment Condition relativa and humidity range, it will Atmospheric 70kPa~ not be used...
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Page 20: Appendix 1 Emc Information
ENGLISH DIA: 25-195 mmHg Pulse rate: 40-199 bpm 2. Accuracy of the cuff pressure : ±3 mmHg (±0.4 Kpa ) Accuracy of the pulse rate:±5% Bluetooth: Arm blood pressure monitor using Bluetooth 4.2 technology, transmitting and receiving frequencies of 2402-2480MHz, modulation type GFSK, effective radiation power of 2.79dBm. Personal health information are not included in handling, storage or transmission(health records ,health histories which include any individual identifiers such as picture, health insurance number, any identification ID or name). The data that can be transferred over Bluetooth are measurement timestamp, measurement error code, systolic pressure, diastolic pressure, pulse rate, irregular pulse, and battery level. 18. Appendix 1 EMC Information Guidance and manufacturer’s declaration - Electromagnetic emission The Arm Blood Pressure Monitor is intended for use in the electromagn- etic environment specified below. The custo- mer or the user of the Arm Blood Pressure Monitor should... -
Page 21: Immunity Test
ENGLISH Harmonic emis- N.A. sions IEC61000-3-2 Voltage fluctua- tions/flick er N.A. emissions IEC61000-3-3 Guidance and manufacturer’s declaration - Electromagnetic immunity The Arm Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Arm Blood Pressure Monitor should assure that it is used in such an environment. IEC 60601 Immunity test Compliance level test level Electrostatic ±8kV contact ±8 kV contact discharge (ESD) IEC ±2 kV,±4kV,±8 kV, ±2 kV,±4 kV, 61000-4-2 ±15kV air ±8 kV,±15 kV air Electrostatic ±8 kV contact ±8 kV contact discharge (ESD) IEC ±2 kV,±4 kV, ±8 ±2 kV,±4 kV,±8 kV,... - Page 22 ENGLISH 10 V/m 10 V/m Radiated RF 80 MHz - 2,7 GHz 80 MHz - 2,7 GHz IEC61000-4-3 80 % AM at 2 Hz 80 % AM at 2 Hz NOTE: UT is the a.c. mains voltage prior to application of the test level Guidance and manufacturer’s declaration - electromagnetic Immunity The Arm Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Arm Blood Pressure Monitor should assure that it is used in such an environment . Radia- Test Band Service Modula- Max. Dis- IEC Com- Frequ- (MHz) tion Power tance 60601- pliance RF0-4-3 ency 1-2 Test level (Test...
- Page 23 IEC61000- Level level (A/m) 4-39 (A/m) (Test 30 kHz specifica- tions for ENCLO- 134,2 kHz Pulse SURE modula- PORT tion IMMU- 2.1 kHz NITY to proximity 13,56 MHz Pulse magnetic modula- fields) tion 50 kHz Statement: “The AOJ-33A of Arm Blood Pressure Monitor was tested according to the recommendations of Technical Report IEC TR 60601-4-2: Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems.”...
- Page 24 ENGLISH Warning: ● Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. ● Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.” ●Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. ●Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Notice: If users or patients have occurred any serious incident that relation to the device, please report to manufacturer and the competent authority of the Member State in which you are established.
- Page 25 Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, 518126 Shenzhen, PEOPLE’S REPUBLIC OF CHINA Certify and declare under our responsibility that the following product: Arm Blood Pressure Monitor Product name AOJ-33A Model No. Brand name V1.0 Hardware version V1.0.0...
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